US Medical Device Submissions
Navigating the FDA submission
channels takes experience.
The Fang Consulting team have a solid understanding of medical device development and can partner with you from development, through testing and submission, to a smooth market entry. Your success is our goal.
The Fang team has experience with FDA submissions. Whether you need a 510(k) or a PMA, we can guide you through the process.
Our staff provides FDA guidance at any step of the process, so your company has a smooth and successful market launch. From providing strategic pathways to leading pre-submission meetings, writing submissions, and answering the FDA’s requests for Additional Information (AIs), the Fang team of consultants are able to lend assistance where needed to get your device on the market successfully.